Device recall
Z-0671-2020: Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein…
FDA device recall · Class II · The Binding Site Group, Ltd.
Key facts
| Recall number (Z-number) | Z-0671-2020 |
|---|---|
| Recall event | 84243 |
| Product | Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum using the Binding Site Optilite analyser. Measurement of C-Reactive Protein aids in evaluation of the… |
| Product code | DCN |
| Recalling firm | The Binding Site Group, Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 27, 2021 |
| 510(k) numbers | K172868 |
| FEI number | 3002808340 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database